Author

Jonathan Gilinski
Jonathan Gilinski
Executive Director
CapsCanada

Thought Leadership

Differentiating Generic SODFs with Hard Capsule Formulations

| Pharma's Almanac
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Solid oral dosage forms (SODFs) remain the preferred formulation method for medications due to their ease of use for patients and caregivers and the lower cost of production compared to other dosage forms. Of the different types of SODFs – tablets, caplets, softgels and hard capsules – hard capsules offer distinct advantages for the formulation of generic drug products. They are not only one of the most cost-effective solutions to develop and manufacture SODFs, but also a more flexible dosage form.

With lower development costs and greater flexibility, hard capsules are the best choice for the formulation of generic solid oral dosage pharmaceuticals.

More Cost-Effective

Cost reduction is an increasing imperative across the entire pharmaceutical industry, but has always been essential for generic drugs. The use of hard capsules for drug delivery simplifies both the development and manufacturing of SODFs. Formulations placed into hard capsules typically require fewer excipients than those produced in tablet form, reducing development time and cost. Raw material costs are also lower, as are the cost and time associated with vendor qualification, inventory management, etc. More importantly, the process of filling a hard capsule is less stressful on the active ingredient than other forms of SODF production.

Furthermore, there are less than half as many steps involved in producing hard capsule drugs than tablets made using a wet or dry granulation step. (Direct-compression tablets don’t require as many steps but there are few of these drugs due to the difficulties in developing suitable powder formulations.) Fewer steps equate to shorter production times and lower production costs.

More Flexible

By their nature, two-piece hard capsules provide more than just cost benefits. They are highly flexible in terms of dosage concentration and delivery method. The capsule composition can also be modified to meet the specific needs of each API/formulation.

Unlike for tablets, which are limited by the tablet press capabilities, a wide range of different dosage concentrations (milligrams per dose) can be achieved with hard capsules by modifying the ratios of excipients. A more-concentrated formulation of an API can be produced in a the same size capsule as a less-concentrated formulation with a smaller ratio of excipients. This flexibility translates into fewer change parts that are required for production and reduced downtime on machines when switching dosage sizes.

Hard capsules also provide formulators with many options regarding the format of the material placed inside the capsules. As a result, they are much more versatile than tablets. Two piece hard capsules can be filled with dry ingredients such as powders, granules, pellets, tablets, or mini-tablets, liquids and semi-solids are also suitable. A combination of these formats can also be used.

At CapsCanada, we offer significant flexibility in the manufacturing of the hard capsules themselves. If the polymer compositions in our standard capsules do not meet the needs of a given API, we use our extensive knowledge and expertise in capsule development and design to create a stable, high-performing capsule formulation that does. With this approach, we transfer some of the development work from our client to our team, often accelerating the project timeline and getting the product to market sooner.

More Difficult to Counterfeit

The introduction of fraudulent medicines into the drug supply is a worldwide problem. The pharmaceutical industry is actively seeking drug delivery systems that are counterfeit resistant. Tamper-resistance is another desirable attribute that goes hand in hand with anti-counterfeiting.

Two-piece hard capsules that are sealed with a band are sophisticated in their appearance and provide drug delivery solutions that are difficult to copy and cannot be reclosed once physically opened. As such, they increase the barriers to counterfeiting and tampering. For instance, a green and white capsule with a purple band is highly distinctive and unmistakable as a certain brand of product. Recreating the exact appearance is difficult. Patients also know that the capsules have not been tampered with if the seal is not broken. This level of protection cannot be achieved for tablets.

These features translate into safer products and also allow for greater brand recognition. Customized banding, in fact, allows for unique branding opportunities. The variety of capsule sizes and capsule and band colors, finishes and printing options allow generic drug manufacturers to differentiate their products while providing assurance of quality.

Greater brand recognition, improved safety and reduced development/manufacturing costs and timelines: it is clear why hard capsules are the best choice for generic solid oral dosage forms.